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GMP Manufacturing of Pharmaceutical Ethanol

Certified GMP Pharmaceutical Manufacturer

  • Manufacturing license according to § 13, Paragraph 1 of the AMG (German Drug Law)
  • Certified GMP pharmaceutical manufacturer according to Article 111 (5), Directive 2001/83/EG


Continuous production monitoring through internal monitoring processes

  • Analysis of pre-finished and finished products in our own laboratory
  • Continuous certification of suppliers and service providers
  • GMP-compliant batch release in accordance with the current version of the European Pharmacopoeia by a qualified person


Delivery to well-known pharmaceutical companies at home and abroad

  • Use of ethanol as active ingredient and excipient
  • Regular audits by pharmaceutical manufacturers


Storage and logistics of pharmaceutical ethanol

  • Separate tanks for the storage of the pharmaceutical ethanol qualities
  • Separate pipelines for storage and retrieval
  • Hermetically sealed product handling
  • GMP-compliant transport through qualified logistics partners
  • Computer-controlled online denaturing

 

GMP-quality management in cooperation with  

 

Ethanol
Anhydrous Ethanol / Pharmaceutical Quality
Active ingredient and additive for pharmaceutical use
  • Absolute Alcohol min. 99.9% vol. (Item No: PH.EUR.520MT2) in accordance with the European Pharmacopoeia


Currently only on request!

Azeotropic Ethanol / Pharmaceutical Quality
Active ingredient and additive for pharmaceutical use
  • Ethanol (Pharmaceutical) min. 96.0% vol. (Item No: PH.EUR.450MT2) in accordance with the European Pharmacopoeia

 

Denaturation

Standard Denaturation (per 100 Liters of pure Alcohol):

  • min. 1 Liter Methyl ethyl ketone (MEK- denaturant)
  • min. 1 Liter pure Methyl ethyl ketone (2 Butanone)